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Eli Lilly & Co.

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Eli Lilly & Co., one of the largest drug manufacturers in the world, is best known for creating the antidepressant Prozac. It has defended numerous lawsuits over the safety and marketing of its products.

Eli Lilly is a Fortune 500 global pharmaceutical manufacturer headquartered in Indianapolis. The company began in 1876 when Colonel Eli Lilly, a cotton-farmer-turned-pharmacist, opened the business in a tiny two-story brick building. His intention: Create the highest quality drugs based on the best and most progressive scientific research.Eli Lilly Logo

In 2014, the company reported net sales of $19.6 billion. It employs 41,000 people worldwide, has manufacturing plants in 13 countries and markets products in 120 countries. Its global business areas consist of diabetes, cancer treatment, animal health, emerging markets and biomedicines (including products related to cardiovascular, urological, neuroscience, autoimmunity and musculoskeletal health). The company is perhaps most well-known for its products Prozac and Cialis.

Despite its success, Eli Lilly has faced its fair share of challenges in the pharmaceutical industry. The company is under fire for manufacturing or helping market a number of drugs with dangerous side effects, including Axiron, Actos, Prozac, Symbyax and Byetta.

History

Lilly was a Civil War veteran, pharmaceutical chemist and former partner in a failed drug-manufacturing company in Illinois. He disapproved of the badly constructed and often ineffective medicines of his time. He launched his own drug-manufacturing company in Indianapolis on May 10, 1876.

The business grew quickly. In 1883, the company produced its first successful drug — Succus Alterans — to treat venereal disease. The revenue from the drug helped the company expand its research and manufacturing efforts. In 1886, Eli Lilly hired a chemist and full-time botanist, becoming one of the first companies to start a pharmaceutical research program.

After the colonel’s death in 1898, his son, Josiah K. Sr. (J.K. Sr.) took over. By 1905, sales hit $1 million. In the 1920s, Lilly worked with researchers at the University of Toronto to develop insulin to treat diabetes, which at the time was fatal. The company offered the first commercially available insulin in 1923.

Fast facts about Eli Lilly & Co.
Established: May 10, 1876
Founder: Colonel Eli Lilly
Headquarters: Indianapolis
Size: More than 41,000 employees worldwide
2014 Revenue: $19.6 billion

In the 1940s, Lilly helped mass-produce the world’s first antibiotic, penicillin. The company filled hundreds of government orders during World War II. By the end of the 1940s, sales hit $100 million. Annual sales shot to $500 million during the 1960s, the decade Lilly introduced a new class of antibiotics that included the brands Keflex and Kefzol. The 1970s saw the launch of Ceclor, which became the best-selling oral antibiotic worldwide.

The company reached sales of $1 billion by the mid-1970s. By that time, the company had 23,000 employees within 39 affiliate companies worldwide. The 1980s were an even bigger boom time for Eli Lilly. The company launched Humulin, a synthetic insulin product, and fluoxetine, more commonly known by its brand name, Prozac. Eventually earning the distinction of the most profitable drug in Lilly’s history, Prozac was the first in a new class of antidepressants called selective serotonin reuptake inhibitors (SSRIs).

Lilly introduced several innovative products throughout the 1990s, including the antipsychotic drug Zyprexa, and Humalog, a fast-acting insulin product. In 1999, the company joined forces with Takeda Pharmaceuticals to market the Type 2 diabetes drug Actos. Lilly launched the erectile dysfunction drug Cialis in the 2000s, as well as the bipolar depression drug Symbyax and a new type of diabetes drug called Byetta.

Eli Lilly continues to manufacture and market multiple drugs, including:

  • Zyprexa, to treat schizophrenia and bipolar disorder
  • Evista, to prevent and treat postmenopausal osteoporosis
  • Axiron, to treat low testosterone due to medical conditions
  • Strattera, to treat attention deficit hyperactivity disorder (ADHD)
  • Symbyax, the first FDA-approved medication specifically for bipolar depression
  • Byetta, to treat Type 2 diabetes
  • Cialis, to treat erectile dysfunction
  • SGLT2 inhibitors, Jardiance and Glyxambi, to treat Type 2 diabetes
  • Erbitux, to treat certain cancers
  • Tradjenta, to treat Type 2 diabetes
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    Problematic Medications

    Although Eli Lilly has helped countless patients find a better quality of life, the company is also responsible for a number of controversial products. Drugs like Actos, Prozac and Axiron come with side effects that led many to take legal action against Lilly. The antipsychotic drug Zyprexa landed the company in court for illegal marketing.

    Axiron

    In 2010, the FDA approved Axiron, the first “underarm” testosterone replacement therapy (TRT) treatment. Men with low or no testosterone associated with a medical condition can apply the drug like deodorant to counter symptoms such as sexual difficulties, osteoporosis and loss of muscle mass.

    With sales of $178.7 million in 2013, Axiron is one of the best-selling testosterone drugs on the market, second only to AbbVie’s AndroGel. Despite the growing success of Axiron and other TRTs, research studies on the long-term safety of testosterone replacement therapy are nonexistent.

    After two recent studies linked testosterone products to a higher risk of heart attack, stroke and death, the FDA announced it will reevaluate the treatment’s safety. Eli Lilly faces legal action alongside other TRT drug manufacturers over the therapy’s risk for heart attack and other adverse events. Thousands of testosterone therapy lawsuits are pending in the U.S. District Court Northern District of Illinois.

    Actos

    Eli Lilly partnered with Japan-based drug manufacturer Takeda to market Actos (pioglitazone) in the U.S. from 1999 to 2009. The oral medication, used to treat Type 2 diabetes, is linked to congestive heart failure and bladder cancer. Complications with the drug led thousands of patients to file lawsuits against both companies.

    In April 2015, Takeda Pharmaceuticals settled thousands of lawsuits for a $2.37 billion Actos settlement. The settlement was one of the largest in U.S. history.

    Byetta

    In 2005, Lilly cooperated with Amylin Pharmaceuticals to introduce Byetta (exenatide), an injectable Type 2 diabetes drug. Both companies are now targets of numerous lawsuits over the drug’s link to serious side effects such as pancreatitis and pancreatic cancer.

    In late 2011, the two companies agreed to end their decade-long partnership and transfer all responsibility of Byetta commercialization and development to Amylin in an effort to resolve outstanding litigation between the two companies. In 2012, Bristol-Myers purchased Amylin for $5.3 billion.

    The FDA began studying the connection between drugs like Byetta and cancer in 2013.

    Tradjenta

    Tradjenta (linagliptin) is an oral medicine doctors prescribe to treat Type 2 diabetes. The drug emerged from a 2011 partnership between Eli Lilly and German manufacturer Boehringer Ingelheim. Like patients taking Byetta, some Tradjenta users reported serious complications like pancreatitis and pancreatic cancer.

    Prozac

    Prozac, an antidepressant that revolutionized the medical landscape, has a low risk of causing birth defects if taken while pregnant and can increase suicidal thoughts and behavior in children and young adults. Patients have targeted Lilly with numerous Prozac lawsuits, claiming the company didn’t properly warn them about the drug’s dangerous side effects.

    Eli Lilly paid more than $50 million by 2000 to settle dozens of lawsuits related to Prozac. The drug remains on the market, although the FDA now requires it to carry a black-box label warning stating that it may increase suicidal thoughts or behavior in young people. So far, the company has refused to admit liability in birth defect cases.

    Zyprexa

    Eli Lilly pleaded guilty in January 2009 to illegal marketing of its drug Zyprexa, which the FDA only approved to treat bipolar disorder and schizophrenia. The company also marketed the drug as a treatment for dementia and for pediatric uses. Lilly paid $1.42 billion to end the criminal investigation and settle civil lawsuits, and another $62 million to settle similar cases in 32 states and Washington, D.C.

    Symbyax

    Symbyax, a drug that combines Prozac and Zyprexa, can have the undesirable side effects of both. Like Prozac, the drug can cause birth defects when taken by pregnant women. Parents reported problems including cleft lip and palate, spina bifida, anencephaly and club foot. Lilly faces lawsuits over Symbyax side effects.

    Diethylstilbestrol

    In January 2013, Lilly settled a lawsuit filed by four sisters who claimed its version of diethylstilbestrol (DES) gave them breast cancer after their mother took it in the 1950s. Eli Lilly and hundreds of other manufacturers marketed the drug as a way to prevent miscarriages. However, a Harvard public health doctor and expert witness in the case explained that DES can cause cancer in the babies of some women who took the drug.

    According to one of the lawyers representing the sisters, Lilly failed to test the drug on pregnant women before marketing it. The FDA issued a recall for DES in 1975. The settlement was for an undisclosed sum, and joins a number of similar cases Lilly has settled, including claims related to cervical and vaginal cancer.

    The Future of Eli Lilly

    Eli Lilly is struggling to overcome a series of setbacks, including patent losses for highly profitable drugs and approval rejections for several new drugs. The company lost billions to competitors when it lost patent protection for Cymbalta, Zyprexa and Humalog.

    The patent on Cymbalta expired in December 2013. As competing companies gained approval for generic versions of the drug, financial pressure prompted Lilly to lay off 30 percent of its U.S. workforce in April 2013.

    Planning to make up for these losses, the company partnered with Boehringer Ingelheim in 2011 and developed several innovative Type 2 diabetes medications. Two of the drugs, Jardiance (empagliflozin) and Glyxambi (empagliflozin and linagliptin), belong to a recently developed class of drugs called SGLT2 inhibitors. The FDA rejected Jardiance in March 2014 citing contamination issues at one of Boehringer’s German facilities before approving it in August 2014. Early in 2015, the FDA warned SGLT2 inhibitors could cause deadly condition called ketoacidosis.

    Despite these challenges, executives maintain a bright outlook for the future of the company. Promising new medications include dulaglutide, another diabetes drug, and ramucirumab — a cancer therapy that failed as a breast cancer treatment, but shows hopeful clinical trial results for lung cancer patients.

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